Condition category
Nervous System Diseases
Date applied
24/05/2005
Date assigned
02/08/2005
Last edited
19/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Massimo Ildebrando

ORCID ID

Contact details

Via Pontina km 30,400
Pomezia (Rome)
00040
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ST200-DM-04-005

Study information

Scientific title

Acronym

Study hypothesis

The clinical hypothesis to be verified is 20% response rate in the placebo group versus 40% response rate in the Acetyl-L-Carnitine group where a responder is defined as a patient having obtained a decrease of at least one grade in the NCI-CTC sensory score at treatment end as compared to baseline.

Please note that this record was updated on 05/11/2007. Changes were made to the countries of recruitment, the inclusion criteria, and the anticipated end date. The previous end date for this trial was 31/12/2006.

Ethics approval

Ethics approval received from the following ethics committees:
1. Università degli Studi G. d'Annunzio on the 21st July 2005
2. Direzione Sanitaria del P.O.S. Gerardo on the 16th September 2005
3. Presidio Arcispedale Santa Maria Nuova on the 9th September 2005
4. dell'A.U.S.L. Roma H on the 19th September 2005
5. Servizio di Farmacia on the 26th September 2005
6. Segreteria del Comitato Etico on the 15th September 2005
7. Comitato Etico per la Sperimentazione clinica dei medicinalion the 6th February 2006
8. Commessione Etico-Scientifica - ASL Rimini on the 12th October 2005
9. Istituto Nazionale per lo Studio e la Cura dei Tumori on the 20th February 2006

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Taxanes- or platinum-induced neuropathy

Intervention

Placebo versus Acetyl-L-Carnitine.

Efficacy:
Neuropathy will be assessed by a neurologist at each study visit using: sensory and motor items of National Cancer Institute - Common Toxicity Criteria (NCI-CTC) version 3.0; vibration examination; total neuropathy score (TNS); clinical neurological evaluation; electroneurography (ENG).

Safety:
Physical examinations, electrocardiograms (ECGs), vital signs, laboratory tests, adverse events and concomitant medications will be considered for the safety and tolerability evaluation.

Intervention type

Drug

Phase

Not Specified

Drug names

Acetyl-L-Carnitine (ST 200)

Primary outcome measures

The sensory item of NCI-CTC version 3.0 dated December 12th 2003 will be the primary endpoint. In accordance with the primary objective of the study, the proportion of responder patients measured at treatment end (i.e. visit 2) will be the primary endpoint.

Secondary outcome measures

1. Motor item of NCI-CTC version 3.0
2. Ulnar, sural and common peroneal nerve conduction velocity (NCV)
3. Symptoms/signs of peripheral damage
4. Vibration perception threshold
5. Total neuropathy score (TNS)
6. Plasma NGF level
All the variables will be descriptively analysed by treatment and visit (mean, median, standard deviation, minimum and maximum for continuous variables, frequency distribution for categorical variables). Efficacy analysis will be applied in all populations. Results from the ITT population will be considered the primary ones.

Overall trial start date

01/07/2005

Overall trial end date

01/06/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 05/11/2007:
Patients (male and female aged 18 or more years and Karnofsky greater than 60) previously treated with taxanes- or platinum-based chemotherapy and presenting sensory neuropathy, will be randomised to receive placebo or Acetyl-L-Carnitine.

Previous inclusion criteria:
Patients (male and female age between 18 and 70 years and Karnofsky >60) previously treated with taxanes- or platinum-based chemotherapy and presenting sensory neuropathy, will be randomised to receive placebo or Acetyl-L-Carnitine.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

172

Participant exclusion criteria

1. Pre-existing neuropathies of different origin than those considered in this trial
2. Diabetes mellitus, insulin-dependent
3. Symptomatic brain metastases
4. Leptomeningeal involvement
5. Significant infective ilness or active inflamed focus
6. Concomitant therapy with other neuroprotective agents
7. Any previous use of neuro-protectant drugs if performed from the last chemoteraphy administration, onwards
8. Any neurotoxic chemotherapy since one month prior to baseline
9. Predictable lack of patient's co-operation
10. Pregnancy, nursing, or women of childbearing potential not using an effective method of birth control
11. Previous treatment with platinum for those patients who enter the study due to taxanes-induced sensory neuropathy
12. Previous treatment with taxanes for those patients who enter the study due to platinum-induced sensory neuropathy

Recruitment start date

01/07/2005

Recruitment end date

01/06/2009

Locations

Countries of recruitment

Belgium, France, Italy

Trial participating centre

Via Pontina km 30,400
Pomezia (Rome)
00040
Italy

Sponsor information

Organisation

Sigma-Tau (Italy)

Sponsor details

Industrie Farmaceutiche Riunite
SpA
Via Pontina km 30,400
Rome
00040
Italy

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Sigma-Tau i.f.r. S.p.A. (Italy) (Protocol ref: ST200-DM-04-005)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes