Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT00001208 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Botulinum Toxin for the Treatment of Involuntary Movement Disorders

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 329 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor

    Re-verified, no change to tracked fields

  2. Minor

    Re-verified, no change to tracked fields

  3. Minor

    Re-verified, no change to tracked fields

  4. Minor

    Eligibility criteria expanded, about 6 words

    Show what changed: Eligibility criteria
    * INCLUSION CRITERIA: 1. Patients 2 years and older, will be eligible for participati [...] reating physician, might be amenable to treatment with BTX. 2. Applicable disorders include but are not limited to dystonia [...] a, spasticity, and spasmodic dysphonia. EXCLUSION CRITERIA: 1. Women who are planning on becoming pregnant, are pregnant or breastfeeding, for the duration of the condition. 2. Subjects who require treatment with an aminoglycoside antibiotic, until treatment is complete. 3. For laryngeal injections, subjects must have a paradoxical v [...]

  5. Minor

    46 amendments

    46 re-verifications since 2025-04-10, no change to tracked fields

    v280-v325

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
BTX has been used since the 1980s in support of the research mission of NINDS. Initial studies were focused on expanding the applicability of BTX treatment to movement disorders and exploring new indications. We evaluated the efficacy of an alternative serotype, type F. Under other protocols, we continue to study the physiology of movement disorders and BTX response. The application of BTX therapy to movement disorders requires an understanding of BTX preparation and handling. The treatment must be tailored to the disorder under treatment and to its expression in the individual patient. Users must know the specific techniques of injection, including the use of EMG and ultrasound guidance. This protocol allows us to train physicians in all aspects of the use of BTX. It also provides us with a cohort of patients, receiving a standard method of treatment and with a stable response to BTX injection, for participation in other protocols on movement disorders and on the responses to BTX injection.
Trial Details
NCT Number NCT00001208
Lead Sponsor National Institute of Neurological Disorders and Stroke (NINDS)
Conditions Movement Disorders
Enrollment 2,000 participants
Start Date
Updated on ClinicalTrials.gov