Incobotulinum Toxin A for Sialorrhea in Parkinson's Disease (PD)/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS) (Xeomin)
Randomized Double Blind Placebo Controlled Cross-Over Study of Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS)
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Participants will be recruited if they have Parkinson's disease, Parkinsonism. Inclusion and exclusion criteria are summarized below. Participants will be screened at the first visit to make sure they are eligible for the trial. They will then undergo baseline testing including neurologic evaluation, questions to assess their memory and cognitive status and evaluation of their disease status using parts of the Unified Parkinsons's Disease Ratings Scale (UPDRS) that are routinely used to follow disease progression. They will be given a questionnaire to evaluate the severity of their drooling. Their saliva production will be measured by having them spit into a cup for 5 minutes, twice.
At the first visit, after making sure they are eligible for the study and performing the baseline testing and procedures, they will be given either Xeomin or placebo (saline injections without medication) injections in the 4 glands that produce saliva. They will not know which injection they received. This visit will take about 2 hours. They will be followed up every month and asked about side effects, have neurologic evaluation and ALS-FRS testing and fill-in the questionnaire for drooling severity. Saliva volume will be measured as done at the first visit. At either Month 4 or 5, participants will receive the second injection. This will be a "cross-over" injection, i.e., if they received Xeomin at the first injection they will receive saline at the second and vice versa. Thus, all participants will receive the study medication Xeomin, either as the first injection or the second injection at 4 months or 5 months. The follow up after the second injection will be one monthly visit for 3 months, with similar evaluations as described above. The follow-up visit will take about 1 hour each.
Studientyp
Phase
- Phase 2
Kontakte und Standorte
Studienorte
-
-
Massachusetts
-
Boston, Massachusetts, Vereinigte Staaten, 02215
- Beth Israel Deaconess Medical Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria: Hypothesis: Xeomin® injections into the parotid and submandibular glands are safe and effective in the treatment of troublesome sialorrhea in patients with PD/Parkinsonism and ALS.
Inclusion criteria are as follows:
For ALS: 1. Patients diagnosed with ALS by el-Escorial Criteria, ages 20-80 with troublesome sialorrhea as defined below**.
For PD/ Parkinsonism: 1. PD, Multiple Systems Atrophy (MSA), or Progressive Supranuclear Palsy (PSP) diagnosed by clinical criteria, ages 20-80 with troublesome sialorrhea as defined below**.
**Troublesome sialorrhea is defined as grade 3 or more (grade 3 is marked excess of saliva with some drooling) or more on the UPDRS Part 2 Sialorrhea grading scale:[33] (Appendix 1)
For both groups:
- Swallowing function: FOIS scale* 5 or greater (see appendix 1 for scale)
- If patients have been treated with other medications for sialorrhea earlier, they should be off the medications at least 4 weeks prior to the baseline evaluation.
- If they are on other medications for sialorrhea at the time of the baseline evaluation, the doses will be held stable throughout the period of the study.
- Women of child bearing age will need to be on a reliable method of birth control for the duration of the study.
Exclusion criteria
For both PD and ALS:
- Current use of Coumadin
- Concurrent significant medical illness.
- History of myasthenia gravis or Lambert-Eaton Syndrome
- Ongoing substance abuse
- History of unreliable follow-up
- Past use of Xeomin® or other botulinum toxin preparations
- Cognitive impairment, defined as a score ≤ 23/30 on the Mini Mental Status Exam.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Xeomin Injections
Fifteen units (0.15 ml) of incobotulinum toxin A injected into each parotid gland and 20 units (0.2 ml) to each submandibular gland for a total dose of 70 units using anatomical landmarks for ALS Twenty units (0.2ml) injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland for a total dose of 100 units using anatomical landmarks for PD/parkinsonism
|
Xeomin 70-100 units injected in the parotid and submandibular glands of subjects
Andere Namen:
|
|
Placebo-Komparator: Placebo
0.15 ml sterile 0.9% saline injected into each parotid gland and 0.2 ml to each submandibular gland using anatomical landmarks for ALS 0.2ml injected into each parotid gland and 0.3 ml to each submandibular gland using anatomical landmarks for PD/parkinsonism
|
Sterile preservative free 0.9% saline
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Change in objectively measured salivary volume between baseline and one month post-injection in the Xeomin group as compared to placebo
Zeitfenster: 7 months
|
7 months
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Pushpa Narayanaswami, ME, Beth Israel Deaconess Medical Center
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Pathologische Prozesse
- Stoffwechselerkrankungen
- Erkrankungen des Gehirns
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Neuromuskuläre Erkrankungen
- Stomatognathe Erkrankungen
- Mundkrankheiten
- Erkrankungen der Basalganglien
- Bewegungsstörungen
- Synucleinopathien
- Neurodegenerative Krankheiten
- Erkrankungen des Rückenmarks
- TDP-43 Proteinopathien
- Proteostase-Mängel
- Speicheldrüsenerkrankungen
- Sklerose
- Parkinson Krankheit
- Motoneuron-Krankheit
- Amyotrophe Lateralsklerose
- Parkinsonsche Störungen
- Sialorrhoe
Andere Studien-ID-Nummern
- 2011P000304
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .