deltatrials
Completed PHASE2 INTERVENTIONAL NCT00108667

Talampanel to Treat Parkinson's Disease

AMPA Receptor Antagonist Treatment of Parkinson's Disease

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

Conditions Parkinson Disease
Interventions IV Levodopa Talampanel
Updated 5 times since 2017 Last updated: Mar 3, 2008 Started: Apr 30, 2005 Completion: Feb 28, 2006
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Parkinson Disease, this trial is completed. The trial is conducted by National Institute of Neurological Disorders and Stroke (NINDS) and has accumulated 5 data snapshots since 2005. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

Objective: to evaluate the acute effects of talampanel, a novel antagonist of AMPA type glutamate receptors, on the severity of parkinsonian signs and levodopa-associated motor response complications. Study Population: patients with moderately advanced Parkinson's disease and dopaminergic therapy related motor complications, between the age of 21 and 80. Study Design: randomized, controlled, proof-of-principle pilot study lasting approximately 7 weeks. Study Outcome Parameters: the pharmacokinetic characteristics of orally administered talampanel will be measured by means of plasma drug assays, its therapeutic efficacy will be evaluated using validated motor function scales, and safety will be monitored by means of frequent clinical evaluations and laboratory tests.

Objective: to evaluate the acute effects of talampanel, a novel antagonist of AMPA type glutamate receptors, on the severity of parkinsonian signs and levodopa-associated motor response complications.

Study Population: patients with moderately advanced Parkinson's disease and dopaminergic therapy related motor complications, between the age of 21 and 80.

Study Design: randomized, controlled, proof-of-principle pilot study lasting approximately 7 weeks.

Study Outcome Parameters: the pharmacokinetic characteristics of orally administered talampanel will be measured by means of plasma drug assays, its therapeutic efficacy will be evaluated using validated motor function scales, and safety will be monitored by means of frequent clinical evaluations and laboratory tests.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

5 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2

  4. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

  5. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE2

    First recorded

Apr 2005

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Institute of Neurological Disorders and Stroke (NINDS)
Data source: National Institutes of Health Clinical Center (CC)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations