deltatrials
Unknown NA INTERVENTIONAL NCT00173745

Treatment of Drooling With Type A Botulinum Toxin in Children With Cerebral Palsy

Treatment of Drooling With Type A Botulinum Toxin A in Children With Cerebral Palsy

Sponsor: National Science and Technology Council, Taiwan

Updated 6 times since 2017 Last updated: Dec 20, 2005 Started: Jun 30, 2003 Completion: Sep 30, 2005
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This NA trial investigates Cerebral Palsy and Drooling and is currently ongoing. National Science and Technology Council, Taiwan leads this study, which shows 6 recorded versions since 2003 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

Sialorrhea, or drooling, has been reported to be a significant problem in 10%to 37% of patients with cerebral palsy. Excessive drooling may cause skin maceration, increased the burden of caregiver, affect articulation of the patients, and increase the risk of aspiration and dehydration. Many options, including various therapies, medications, surgeries and radiation, have been proposed to treat drooling. Yet none of these is universally successful and many have potential complications. Nerve endings of the parasympathetic post-ganglionic neurons secret aceylcholine. Botulinum toxin should be able to inhibit salivary gland secretion by blocking the release of acetylcholine. Very limited case series had proved fair result of botulinum toxin injection to treat drooling. However, most of the subjects were adult patients with neurological disorders. The purpose of this study is to evaluate the effectiveness of botulinum toxin injection to treat drooling in children with cerebral palsy, and to find the most appropriate dosage, duration of effect and side effects.

Sialorrhea, or drooling, has been reported to be a significant problem in 10%to 37% of patients with cerebral palsy. Excessive drooling may cause skin maceration, increased the burden of caregiver, affect articulation of the patients, and increase the risk of aspiration and dehydration. Many options, including various therapies, medications, surgeries and radiation, have been proposed to treat drooling. Yet none of these is universally successful and many have potential complications. Nerve endings of the parasympathetic post-ganglionic neurons secret aceylcholine. Botulinum toxin should be able to inhibit salivary gland secretion by blocking the release of acetylcholine. Very limited case series had proved fair result of botulinum toxin injection to treat drooling. However, most of the subjects were adult patients with neurological disorders. The purpose of this study is to evaluate the effectiveness of botulinum toxin injection to treat drooling in children with cerebral palsy, and to find the most appropriate dosage, duration of effect and side effects.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotUnknown Status~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotUnknown Status~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – ~Jun 2025 · 9 months · monthly snapshotUnknown~Jun 2025 – present · 10 months · monthly snapshotUnknown

Change History

6 versions recorded
  1. Jun 2025 — Present [monthly]

    Unknown NA

  2. Sep 2024 — Jun 2025 [monthly]

    Unknown NA

  3. Jul 2024 — Sep 2024 [monthly]

    Unknown NA

    Status: Unknown StatusUnknown

  4. Jan 2021 — Jul 2024 [monthly]

    Unknown Status NA

  5. Jun 2018 — Jan 2021 [monthly]

    Unknown Status NA

Show 1 earlier version
  1. Jan 2017 — Jun 2018 [monthly]

    Unknown Status NA

    First recorded

Jun 2003

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Science and Technology Council, Taiwan
  • National Taiwan University Hospital
Data source: National Taiwan University Hospital

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

Study Locations